Conference Description:

Overview:
This webinar will help you understand the FDA's current thinking on

computer systems that are validated and subject to inspection and audit.

Areas Covered in the Session:
21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
Data Archival to ensure security, integrity and compliance
Validation Strategy that will take into account the system risk assessment

and system categorization (GAMP V) processes
Recent FDA findings for companies in regulated industries

Who Will Benefit:
Anyone who is involved in the development, testing, manufacturing,

storage, handling and distribution of product must understand and

conform to FDA requirements for data quality and integrity, and computer

system validation (CSV)
Finally, anyone who is acting as a consultant or contractor to a company

in an FDA-regulated industry should attend to ensure they are able to

bring the most current knowledge and expertise to their assignment

Speaker Profile:
Carolyn (McKillop) Troiano has more than 35 years of experience in the

tobacco, pharmaceutical, medical device and other FDA-regulated

industries. She has worked directly, or on a consulting basis, for many of

the larger pharmaceutical and tobacco companies in the US and Europe,

developing and executing compliance strategies and programs.

Event Fee: One Dial-in One Attendee Price: US$290.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]